Summary

ICU Medical is a global medical device company specializing in infusion therapy, critical care, and oncology applications. Founded in 1984 and headquartered in San Clemente, California, the company develops, manufactures, and sells innovative medical devices used in hospitals and alternate care settings worldwide. ICU Medical's product portfolio includes infusion pumps, IV sets, closed systems for hazardous drug preparation, needle-free connectors, and critical care monitoring devices. The company is particularly known for its expertise in infusion therapy safety, having pioneered technologies that reduce medication errors and prevent bloodstream infections. With a strong focus on patient safety and clinical outcomes, ICU Medical serves healthcare providers across more than 90 countries. The company has grown through strategic acquisitions, including the purchase of Pfizer's Hospira infusion therapy business, which significantly expanded its global footprint and product offerings. ICU Medical maintains a commitment to quality, innovation, and improving patient care through advanced medical technology solutions.

Job description

Essential Duties & Responsibilities

Keep work area and equipment clean
Experienced in the use of SmartScopes or vision systems and writing efficient and accurate routine/programs
Able to read and understand procedures
Strong verbal and written communication skills
Ability to communicate thoughts and ideas interdepartmentally (Eng., Quality, Production)
Perform inspection to ensure good quality
Recognize and communicate deviations from accepted practices
Product sampling and subsequent part inspection according to specifications
Must be motivated and capable of dictating priorities when needed
Ability to adapt to changes in project priorities
Understands and follow cGMP
Assist QA Inspectors and Molding personnel in the interpretation of part drawings, specifications and QA standards
Trains Molding QA personnel on measurement methods and to execute routines
Strong collaboration with engineering and design team for solutions and/or new ideas
Other duties as assigned

Knowledge, Skills & Qualifications

Basic Microsoft (Outlook, Excel, Word) and computer experience
Able to read and understand procedures
Ability to learn and understand new routine program software
Basics of part fixture design
Basics of statistics; such SPC and Gage R&R
Basic Math skills (Basic Algebra)
Strong verbal and written communication skills
Advanced knowledge in reading, interpreting, and understanding drawings and specifications
ASQ Certified Inspector Certification a plus
Experienced in the use of hand gauges (calipers, micrometers, height/depth gauges, etc.)
Capable of making Quality decisions (within allowable limits) to ensure good quality product
Able to perform complex visual and functional tests and investigations on product. Capable of using test and investigation data to determine appropriate course of action on product
Occasional backup for team lead
Demonstrate leadership, problem solving skills and technical knowledge

Education and Experience

High school diploma or GED required
Minimum of 3 years in a quality control environment or FDA regulated manufacturing environment or ASQ/CQI Certification
Minimum of 1 year developing measurement routines in vision systems

Minimum Qualifications

Must be 18 years of age

Travel Requirements

Typically requires travel less than 5% of the time

Physical Requirements and Work Environment

Must be able to perform visual inspections with and without the aid of magnification tools
While performing the duties of this job, the employee is regularly required to talk or hear
This job operates in a clean room environment
While performing the duties of this job, the employee may be required to sit or stand for the duration of the shift
Must be able to repetitively move and lift objects of up to 30 lbs

Requirements

High school diploma or GED required
Minimum of 3 years in a quality control environment or FDA regulated manufacturing environment or ASQ/CQI Certification
Minimum of 1 year developing measurement routines in vision systems
Must be 18 years of age
Experienced in the use of SmartScopes or vision systems and writing efficient and accurate routine/programs
Able to read and understand procedures
Strong verbal and written communication skills
Ability to communicate thoughts and ideas interdepartmentally (Eng., Quality, Production)
Perform inspection to ensure good quality
Recognize and communicate deviations from accepted practices
Product sampling and subsequent part inspection according to specifications
Must be motivated and capable of dictating priorities when needed
Ability to adapt to changes in project priorities
Understands and follow cGMP
Assist QA Inspectors and Molding personnel in the interpretation of part drawings, specifications and QA standards
Trains Molding QA personnel on measurement methods and to execute routines
Strong collaboration with engineering and design team for solutions and/or new ideas
Basic Microsoft (Outlook, Excel, Word) and computer experience
Ability to learn and understand new routine program software
Basics of part fixture design
Basics of statistics; such SPC and Gage R&R
Basic Math skills (Basic Algebra)
Advanced knowledge in reading, interpreting, and understanding drawings and specifications
Experienced in the use of hand gauges (calipers, micrometers, height/depth gauges, etc.)
Capable of making Quality decisions (within allowable limits) to ensure good quality product
Able to perform complex visual and functional tests and investigations on product
Capable of using test and investigation data to determine appropriate course of action on product
Occasional backup for team lead
Demonstrate leadership, problem solving skills and technical knowledge
Must be able to perform visual inspections with and without the aid of magnification tools
Must be able to repetitively move and lift objects of up to 30 lbs

Company overview

ICU Medical is a global medical device company specializing in infusion therapy, critical care, and oncology applications. Founded in 1984 and headquartered in San Clemente, California, the company develops, manufactures, and sells innovative medical devices used in hospitals and alternate care settings worldwide. ICU Medical's product portfolio includes infusion pumps, IV sets, closed systems for hazardous drug preparation, needle-free connectors, and critical care monitoring devices. The company is particularly known for its expertise in infusion therapy safety, having pioneered technologies that reduce medication errors and prevent bloodstream infections. With a strong focus on patient safety and clinical outcomes, ICU Medical serves healthcare providers across more than 90 countries. The company has grown through strategic acquisitions, including the purchase of Pfizer's Hospira infusion therapy business, which significantly expanded its global footprint and product offerings. ICU Medical maintains a commitment to quality, innovation, and improving patient care through advanced medical technology solutions.